23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sontro® OTC Hearing Aids (AI)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BD BBL™ Taxo™ Differentiation Discs for Nystatin
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902315506·BD BBL™ Taxo™ Differentiation Discs for Nystati...
devemed
FDA UDI
devemed GmbH·04061644020867·Suture and membrane tweezers
I = 2.2 mm, angled...
HEART SYNC
FDA 510(k)
FDA Class 3
·Cardiovascular
REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
Reicodent
FDA UDI
devemed GmbH·04061644063208·Suture and membrane tweezers
I = 2.2 mm, angle...
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 22, 2011
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 15, 2013
COBALT HV W/ GENTAMICIN POWDER BONE CEMENT 40 GRAMS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·October 2, 2017
COBALT HV W/ GENTAMICIN POWDER BONE CEMENT 40 GRAMS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·October 6, 2017
BD DIFCO PURPLE BROTH BASE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 25, 2021
EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDS·November 25, 2025
ONCOLOGY SALVAGE SYSTEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 10, 2017
ONCOLOGY SALVAGE SYSTEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 10, 2017
2710 CLEARTRACE LT
FDA Adverse Event
Other
·CONMED CORPORATION·Product code GXY·April 13, 2007
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025